MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH, ADVANCED THERAPIES AXIOM ICONOS R200; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number 10093961

Device Problem Use of Device Problem (1670)

Patient Problems Injury (2348); Patient Problem/Medical Problem (2688)

Event Date 01/11/2016

Event Type  Injury  

Manufacturer Narrative

The system is equipped with safety switches that should stop all system movement in case of collision with foreign object.In the reported case, the applied force to the hand was limited as the cover underneath the table is flexible.When the cover is bent due to the pressure applied by an obstacle, the safety switches should be activated and stop motorized movement immediately.According to the description in the user manual axd3-340.620.14 (pages 35 and 53), the operator may release system movements only after ensure that no person is endangered and that the handgrips are properly used.(b)(6).

Event Description

It was reported that a patient's hand was trapped under the table top on the axiom iconos r200 system.The hand was caught between the spotfilm device and edge of the table.When the hand got trapped, all table movements were disabled and it was hard to move the table to free patient's hand.As a result of the incident, the patient suffered from a puncture wound and a broken bone.An x-ray examination followed the adverse event.The patient received medical treatment at the facility.Further information regarding the treatment was requested.The reported event occurred in (b)(6).

• Brand Name: AXIOM ICONOS R200
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH, ADVANCED THERAPIES; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH, ADVANCED THERAPIES; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 8560208
• MDR Text Key: 143395696
• Report Number: 3004977335-2016-30340
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K992660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10093961
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/12/2016
• Initial Date FDA Received: 04/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other